A Study of Lebrikizumab in Patients Whose Asthma is Uncontrolled With Inhaled Corticosteroids and A Second Controller Medication (LUTE)

March 3, 2015 updated by: Genentech, Inc.

A Phase III, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of Lebrikizumab in Patients With Uncontrolled Asthma Who Are on Inhaled Corticosteroids and A Second Controller Medication

This randomized, multicenter, double-blind, placebo-controlled, parallel-group study will assess the efficacy and safety of lebrikizumab in patients with asthma whose disease remains uncontrolled despite daily therapy with an inhaled corticosteroid and a second controller medication. Patients will be randomized in a 1:1:1:1 ratio to receive double-blind treatment with subcutaneous lebrikizumab ("highest", "middle", "lowest" dose) or placebo every 4 weeks for 52 weeks, in addition to their standard-of-care therapy. This will be followed by a 52-week double-blind active treatment extension. The anticipated time on study treatment is up to 104 weeks. There will be a safety follow-up of 24 weeks after the last dose of study drug for all patients.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
258

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
  • United States
    • Alabama
      • Pell City, Alabama, United States, 35128
    • Arizona
      • Scottsdale, Arizona, United States, 85251
      • Scottsdale, Arizona, United States, 85266
      • Tucson, Arizona, United States, 85712
    • California
      • Bakersfield, California, United States, 93301
      • Fountain Valley, California, United States, 92708
      • Fullerton, California, United States, 92835
      • Los Angeles, California, United States, 90048
      • Los Angeles, California, United States, 90025
      • Mission Viejo, California, United States, 92691
      • Napa, California, United States, 94558
      • Orange, California, United States, 92868
      • Rancho Mirage, California, United States, 92270
      • Sacramento, California, United States, 95819
      • San Diego, California, United States, 92108
      • Studio City, California, United States, 91607
      • Upland, California, United States, 91786
      • Walnut Creek, California, United States, 94598
    • Colorado
      • Centennial, Colorado, United States, 80112
      • Colorado Springs, Colorado, United States, 80907
      • Denver, Colorado, United States, 80206
      • Wheat Ridge, Colorado, United States, 80033
    • Connecticut
      • Waterbury, Connecticut, United States, 06708
    • Florida
      • Gainesville, Florida, United States, 32605
      • North Palm Beach, Florida, United States, 33408
      • Ocala, Florida, United States, 34471
      • Tallahassee, Florida, United States, 32308
      • Tampa, Florida, United States, 33613
      • Winter Park, Florida, United States, 32789
    • Georgia
      • Albany, Georgia, United States, 31707
      • Savannah, Georgia, United States, 31406
    • Hawaii
      • Honolulu, Hawaii, United States, 96814
    • Illinois
      • River Forest, Illinois, United States, 60305
    • Kansas
      • Topeka, Kansas, United States, 66606
    • Louisiana
      • Metairie, Louisiana, United States, 70006
    • Maine
      • Bangor, Maine, United States, 04401
    • Missouri
      • Kansas City, Missouri, United States, 64114
    • Nebraska
      • Bellevue, Nebraska, United States, 68123
    • Nevada
      • Las Vegas, Nevada, United States, 89119
      • Las Vegas, Nevada, United States, 89106
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131
    • New York
      • Bronx, New York, United States, 10461
      • Great Neck, New York, United States, 11021
      • New York, New York, United States, 10016
      • Rockville Centre, New York, United States, 11570
    • North Carolina
      • High Point, North Carolina, United States, 27262
      • Wilmington, North Carolina, United States, 28401
    • Ohio
      • Cincinnati, Ohio, United States, 45231
    • Oregon
      • Eugene, Oregon, United States, 97401-7721
      • Lake Oswego, Oregon, United States, 97035
      • Portland, Oregon, United States, 97202
    • Pennsylvania
      • Blue Bell, Pennsylvania, United States, 19422
      • Easton, Pennsylvania, United States, 18045
      • Harrisburg, Pennsylvania, United States, 17110
      • Philadelphia, Pennsylvania, United States, 19115
      • Upland, Pennsylvania, United States, 19013
    • Rhode Island
      • Warwick, Rhode Island, United States, 02865
    • South Carolina
      • Greenville, South Carolina, United States, 29607
      • Spartanburg, South Carolina, United States, 29303
    • Tennessee
      • Knoxville, Tennessee, United States, 37909
    • Texas
      • Arlington, Texas, United States, 76018
      • Dallas, Texas, United States, 75230
      • El Paso, Texas, United States, 79925
      • Fort worth, Texas, United States, 76109
      • McKinney, Texas, United States, 75069
      • San Antonio, Texas, United States, 78251
      • San Antonio, Texas, United States, 78224
    • Virginia
      • Henrico, Virginia, United States, 23233
    • Washington
      • Seattle, Washington, United States, 98105
    • Wisconsin
      • Madison, Wisconsin, United States, 53792

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult patients, 18 to 75 years of age at Visit 1
  • Asthma diagnosis for >/= 12 months prior to the start of screening (Visit 1)
  • Bronchodilator response during screening
  • Pre-bronchodilator FEV1 40%-80% of predicted during screening
  • On ICS (inhaled corticosteroids) 500-2000 mcg/day of fluticasone propionate DPI or equivalent for >/= 6 months prior to the start of screening (Visit 1) with no anticipated changes throughout the study
  • On an eligible second controller medication (LABA, LAMA, LTRA or theophylline within the prescribed dosing range)
  • Uncontrolled asthma as defined by protocol both during screening period and at time of randomization
  • Chest X-ray or computed tomography (CT) scan obtained within 12 months prior to screening or chest X-ray during screening period confirming the absence of other lung disease
  • Demonstrated adherence with controller medication during the screening period

Exclusion Criteria:

  • History of severe allergic or anaphylactic reaction to a biologic agent or known hypersensitivity to any component of the lebrikizumab injection
  • Use of zileuton or roflumilast within 6 months prior to screening
  • Maintenance oral corticosteroid therapy, defined as daily or alternate day oral corticosteroid maintenance therapy within the 3 months prior to Visit 1
  • Treatment with systemic (oral, intravenous or intramuscular) corticosteroids within the 4 weeks prior to Visit 1
  • Major episode of infection within 4 weeks prior to Visit 1 or treatment with oral antibiotics within 2 weeks prior to Visit 1
  • Active parasitic infection within the 6 months prior to Visit 1
  • Active tuberculosis requiring treatment within the 12 months prior to Visit 1
  • Known immunodeficiency, including, but not limited to, HIV infection
  • Evidence of acute or chronic hepatitis or known liver cirrhosis
  • History of cystic fibrosis, chronic obstructive pulmonary disease, and/or other clinically significant lung disease other than asthma
  • Known malignancy or current evaluation for a potential malignancy
  • Current smoker or former smoker with a history >10 pack years
  • History of alcohol, drug or chemical abuse
  • Initiation or change in allergen immunotherapy within 3 months prior to Visit 1
  • Use of biologic therapy including omalizumab during 6 months prior to Visit 1
  • Receipt of live/attenuated vaccine within 4 weeks prior to Visit 1
  • Pregnant or lactating women
  • Body mass index (BMI) > 38 kg/m2
  • Body weight < 40 kg

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: placebo
Drug: placebo
subcutaneous dose every 4 weeks
Experimental: lebrikizumab - highest dose
Drug: lebrikizumab
subcutaneous dose every 4 weeks
Experimental: lebrikizumab - lowest dose
Drug: lebrikizumab
subcutaneous dose every 4 weeks
Experimental: lebrikizumab - middle dose
Drug: lebrikizumab
subcutaneous dose every 4 weeks

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Rate of asthma exacerbations during the 52-week placebo-controlled period
Time Frame: weeks 0-52
weeks 0-52

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Change in lung function: pre-bronchodilator FEV1
Time Frame: from baseline to week 52
from baseline to week 52
Time to first asthma exacerbation
Time Frame: from baseline to week 52
from baseline to week 52
Change in fractional exhaled nitric oxide (FeNO)
Time Frame: from baseline to week 52
from baseline to week 52
Change in asthma-specific health-related quality of life, assessed by the Standardized Asthma Quality of Life Questionnaire (AQLQ[S])
Time Frame: from baseline to week 52
from baseline to week 52
Change in asthma rescue medication use
Time Frame: from baseline to week 52
from baseline to week 52
Rate of urgent asthma-related health care utilization during the 52-week placebo-controlled period
Time Frame: from baseline to week 52
from baseline to week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Genentech, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 1, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 1, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 6, 2012

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 5, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 3, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GB27862
  • 2011-004218-41 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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